Patient safety and medical liability reform are key issues being faced by the U.S. health care system. Innovative strategies combining solutions to minimize preventable harms while curbing medical liability risk are rare. One such strategy, embedded in a culture of transparency and full disclosure, is being open and honest with patients, colleagues, and institutions when a patient suffers harm. Disclosure and early offer programs have received modest attention;however, widespread adoption has been impeded by a dearth of rigorous studies evaluating effectiveness in terms of patient safety and medical liability outcomes. To address this issue, we propose a demonstration project to evaluate the effectiveness of a comprehensive process for responding to patient harm events known as the "Seven Pillars" that has been in place at the University of Illinois at Chicago (UIC) since 2006. The long-term objectives of the project are to improve patient safety and mitigate medical liability risk through improved communication with patients and families, disclosure and early offer when patients suffer preventable harm, and by learning from mistakes to prevent future harms - the hallmarks of the "Seven Pillars". The short term objectives of the project are to determine the feasibility of implementing the "Seven Pillars" process at hospitals in the Chicagoland area and to evaluate its impact on patient safety and medical liability. To achieve these objectives, the project will pursue the following specific aims: 1) Refine and improve the "Seven Pillars" process currently in place at the UIC, and facilitate the implementation of the process at nine hospitals within the Chicagoland area;2) Assess the impact of the "Seven Pillars" process on a variety of patient safety process and outcome measures (e.g., number of adverse event reports, numbers of reported significant adverse events, patient safety culture, number and quality of disclosures, etc.);and 3) Assess the impact of the "Seven Pillars" process on a variety of risk management and medical liability process and outcome measures (e.g., number of claims, time to settlement agreement, malpractice premiums, proportion of settlement received by patient or family, etc.). The purpose of this investigation is to determine whether an organizational change intervention based on the "Seven Pillars" approach to patient harm incidents can produce measurable improvements on a targeted set of safety, communication process, and liability outcomes. The basic design will be an interrupted time series with a non- equivalent, no-treatment control group that will be employed to test the following hypotheses: 1) The "Seven Pillars" process currently in place at UIC can be effectively and efficiently disseminated to other hospitals within the Chicagoland area;2) Implementation of the "Seven Pillars" process will bring about improvements in a wide range of patient safety process and outcome measures;and 3) Implementation of the "Seven Pillars" process will bring about significant improvements in a wide range of financial, medical liability, and risk management process and outcome measures. PUBLIC HEALTH RELEVANCE: This project aims to rigorously evaluate the impact of the "Seven Pillars" - a comprehensive response to patient harm that links effective and honest communication with improvements in patient safety and reducing medical liability risk. Consistent with AHRQ's stated goals for the grant this model puts patient safety first, works to reduce to preventable injuries through effective communication among patients and providers, while ensuring fair and timely compensation for inappropriate medical care, and reducing medical liability premiums. This three-year demonstration project is expected to be a catalyst for adoption of a sustainable "Seven Pillars" model throughout the State of Illinois.